Collecting accurate, reliable data in clinical trials once meant trial visits. Patients diligently taking the medication or intervention would trek to the nearest trial center to undergo a battery of tests before being shuttled home. But as decentralized clinical trials (DCTs) sweep through clinical and pharmaceutical research, there’s a new data collection method in town: health wearables.
Pioneered initially by the fitness industry, health wearables allow trial participants to be continuously monitored without leaving the comfort of home. Less burdensome, less costly, and less prone to human error, these medical wearables are what’s powering the DCT revolution.
Little wonder management consulting firm Kaiser Associated predicted in 2018 that by 2025, 70% of trials would incorporate some form of wearable or fitness tracker1 – and that was before the pandemic.
What are Wearables in Healthcare?
‘Health wearables,’ ‘medical wearables,’ or just ‘wearables’ are electronic devices that collect a person’s vital signs. Using the cloud, they log this information into a central database. For consumer wearables and fitness trackers, individuals can access the data via the brand’s online portal.
However, in clinical trials, there remains a significant lack of a simple, efficient, and easy-to-use platform to track data from multiple healthcare wearables (something CDConnect fixes).
As of 2021, 39% of Americans own a smartwatch or health and fitness tracker2. Meanwhile, globally, the wearable market is expected to grow to nearly $115 billion by 2028 – up from $35 billion in 20203.
Ranging from blood pressure watches to sleep trackers, these devices service multiple functions. Some of the most common vital signs monitored include:
Pros and Cons of Health Wearables in DCTs
Nothing is ever perfect. Even wearables, despite their growing importance, come with a few downsides. Let’s go through the pros and cons:
Pros of Healthcare Wearables and Fitness Trackers:
- Remote Monitoring. Fewer trial visits and continuous or frequent data collection are the primary benefits. No long journey for participants could lead to increased patient adherence.
- Richer Data Collection. Trial visits only provided a snapshot of a patient’s health. Medical wearables deliver 24/7 data collection, helping to capture rare events of fluctuations that could be missed in traditional check-ins.
- Increased Accessibility. Including individuals in remote areas or those who have difficulty traveling to a trial site opens DCTs to a broad, diverse selection of participants previously inaccessible.
Cons of Healthcare Wearables and Fitness Trackers:
- Data Reliability and Accuracy. Current wearables, even medical wearable blood pressure devices, vary in accuracy. Incorrect or inconsistent reading could significantly affect the trial outcomes.
- Data Privacy Concerns. Forty percent of fitness tracker consumers are concerned about the privacy of the data being collected4. DCTS are no different. Participants rightly worry about the storage, transmission, and potential misuse of this personal data.
9 Uses for Health Wearables in Decentralized Clinical Trials
Not sure how a medical wearable could boost your DCT? The possibilities are endless. Here are a few options currently being considered or explored:
1. Remote Patient Engagement
Send reminders to patients about taking medications, completing surveys, or performing specific tasks related to the trial. Consistent engagement and tracking allow you to see whether and how participants engage with the trial.
2. Adverse Event Detection
See blood pressure spiking on the blood pressure watch? Notice a sudden drop in blood glucose? Detecting adverse events is a core aspect of clinical trials (aka pharmacovigilance). Through integrated algorithms and continuous data collection, wearables can help identify unusual patterns or data anomalies indicative of potential adverse events. Clinical trials have never been safer!
3. Patient Feedback Collection
It is not a feature of all health wearables, but some allow patients to input data or feedback manually. This could include:
- Mood ratings
- Pain levels
- Perception of sleep quality
- Qualitative notes about an experience
4. Identify At-Risk Patients
Certain constellations of symptoms point toward an impending medical event – be it a heart attack, diabetic ketoacidosis, fall, etc. Doctors and researchers evaluating the real-time data can spot these signs (augmented by advanced algorithms) and contact a participant to see how they’re feeling.
Such participants can then receive higher-level treatment and observations to safeguard their health.
5. Geolocation and Environmental Data
Wearables equipped with GPS can record a patient’s location. Combined with environmental data, this information is extremely useful in trials studying environmental exposures or activity patterns in specific geographical settings.
For example, an analysis of asthmatics could combine the participant data collection with regional air quality levels.
6. Real-world Movement Analysis
Beyond just counting steps, advanced wearables analyze a participant’s gait, posture, or even detect falls – critical for trials related to neurodegenerative conditions, orthopedics, or geriatric populations.
7. Perform Long-Term Sleep Studies
Sleep studies aren’t always reliable. Usually conducted in hospitals, they suffer from a critical flaw – half your brain stands guard when sleeping in a new location.
Accelerometers, heart rate sensors, and other wearables allow researchers to monitor sleep stages, duration, and disruptions from the comfort of the participant’s home.
8. Adherence and Dropout rates
By monitoring wear time, researchers can assess how consistently participants use the wearables and potentially anticipate and mitigate reasons for dropouts.
9. Behavioral Patterns
Wearables can monitor walking, running, and sedentary activities. Some even monitor and analyze patterns like screen time, social interactions, and daily routines relevant to mental health studies or lifestyle interventions.
Closing Thoughts
Health wearables and fitness trackers have transformed decentralized clinical trials through continuous data collection in real-world settings. Not only do these devices enhance the depth and breadth of patient data, but they also improve trial accessibility and patient engagement.
As the wearable market expands, its role in reshaping clinical research methodologies will continue revolutionizing the sector. The only missing piece of the puzzle is a one-stop centralized database to collect, analyze, and store wearable data from multiple participants and devices.
Enter CDConnect – a new, easy-to-use platform created to seamlessly collect data and display trends in an at-a-glance dashboard.
Want an interactive demonstration? Get in touch with our team to learn more.
Sources:
- Mittermaier M, Venkatesh KP, Kvedar JC. Digital health technology in clinical trials. NPJ Digital Medicine. 2023 May 18;6(1):88.
- https://www2.deloitte.com/us/en/insights/industry/telecommunications/connectivity-mobile-trends-survey.html
- https://www.fortunebusinessinsights.com/fitness-tracker-market-103358
- https://www2.deloitte.com/uk/en/insights/industry/technology/wearable-technology-healthcare-data.html/
